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Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.

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Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.

Speakers

Sample of Keynote Speakers and their Case Studies

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Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.

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Astellas logo.svg
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Yuri van Geertruij

Executive Director, Sub-Regional Lead for Mid-Sized Markets

CASE STUDY

Creating Value for Patients: Integrating Regulatory Affairs and Pharmacovigilance

In today’s pharmaceutical environment, consolidating RA and PV can deliver significant advantages – a common strategic focus on maximising portfolio success for the ultimate benefit of patients. This session is about sharing a journey of transforming two functions into a single organisation.

In this session, I’ll explore the critical role of being the bridge between product and technology, where true product development excellence happens. Drawing on my experience in transformation, including agile transformation and large-scale delivery, I’ll share how connecting vision with execution, and people with purpose leads to better collaboration, stronger outcomes, and more impactful products — the cornerstone of product and agile excellence.

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Johnson Johnson New 2023 Vertical Logo Vector.svg
Katherine Tyner Johnson Johnson

Katherine Tyner

Senior Director, Regulatory Policy Leader EMEA & CMC

CASE STUDY

When Innovation Meets Faster Than Regulations - Collaborating to Advance Transformational Medical Products

Innovation throughout the entire drug development lifecycle. Rapid advances in pharmaceutical science—spanning gene and cell therapies, digital health technologies, artificial intelligence–driven drug development, and novel clinical trial designs—are increasingly outpacing the pace of regulatory evolution. This innovation–regulation gap presents both challenges and opportunities for industry and regulatory authorities, particularly the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Proactive, structured partnerships offer a path to ensure that regulatory frameworks remain fit for purpose while enabling timely patient access to safe, effective, and high‑quality therapies.

Collaborative mechanisms such as parallel scientific advice, innovation offices, regulatory sandboxes, qualification programs, and real‑world evidence pilots allow regulators and developers to co‑create scientific understanding, reduce uncertainty, and accelerate development pathways. This abstract explores how coordinated engagement between pharmaceutical companies and regulatory bodies can support regulatory agility, promote global harmonisation, and foster responsible innovation in an era where scientific discovery is moving at unprecedented speed.

Show More

Three years ago, we set out to rebuild our organisation around the customer journey, rather than brands and channels. We introduced agile, cross-functional teams and created new roles, which are accountable for optimising key touchpoints across personas and channels. Through regular huddles with the Field Force, Medical, and Content Strategy teams, we turned insights from the field into rapid experiments and visible improvements. In this session, I will share how we designed these roles, how the huddles work in practice, and what we learned, both culturally and structurally, along the way.

TevaPharm
Nina Raic Teva Pharmaceuticals

Nina Raic

Senior Director Regulatory Affairs

CASE STUDY

Navigating Complexity into Predictable Outcomes: Regulatory Excellence in Emerging Markets

Emerging markets present some of the most diverse and fast-evolving regulatory environments in the world, marked by varying requirements, language barriers and limited harmonisation. For global organisations, this complexity can create unpredictability, operational risks and barriers to timely submissions and approvals. Presentation explores a strategic risk-model approach to transforming regulatory complexity into predictable outcomes. Drawing from real-world operational challenges, it highlights how structured data models, aligned terminology, clear governance, and capability setting can reduce variability and strengthen decision-making. Participants will gain a framework that can help enhance regulatory consistency, improve data quality and build future-ready regulatory operations that remain resilient in the face of changing global regulatory environments.

Show More
Gedeon Richter 199x
Urszula Scieszko Fic Gedeon richter

Urszula Ścieszko-Fic

Global Regulatory Intelligence & Regional Office Head

CASE STUDY

Beyond Compliance: How Regulatory Intelligence Drives Business Decisions

Regulatory Affairs is no longer a support function – it is a strategic driver of business performance. In an environment defined by acceleration, digitalisation, and zero tolerance for error, companies that fail to integrate regulatory intelligence into decision-making risk delays, inefficiencies and lost opportunities.

 This session explores how global regulatory trends are reshaping the role of Regulatory Affairs – from execution to strategy – and how organisations can translate intelligence into faster approvals, better portfolio choices and sustainable competitive advantage.

At Accor, our journey in embedding Strength-Based Leadership and building an ecosystem of coaches is a strategic priority and a cornerstone of our people development philosophy.

In our pursuit of a coaching culture, we’ve implemented a range of initiatives that bring together the best different developmental resources. These initiatives are not standalone programmes; they are part of a deliberate, connected effort to empower our leaders and teams. By focusing on individual and collective strengths, and grounded in core coaching principles, we are shaping a workplace where continuous learning, empathy, and performance go hand in hand. This culture fosters not only personal growth but also drives team resilience, engagement, and business impact.

Rather than just talking about the theory, we want you to hear directly from our leaders. They will share how adopting a coaching mindset has transformed their leadership and the tangible difference it has made for their teams and the organisation as a whole.

Show More
Boehringer Ingelheim Logo.svg
Sheila Elz Boehringer Ingelheim

Sheila Elz

Senior Regulatory Information Manager

CASE STUDY

Data Quality by Design: How IDMP Ontology Accelerates Global Regulatory Harmonisation

As regulatory ecosystems shift toward data‑driven, modular, and globally aligned operating models, the quality and interoperability of regulatory data are becoming decisive strategic differentiators. This presentation explores how strong data foundations—governance, metadata discipline, and cross‑system interoperability—enable organisations to turn data into strategy rather than into an operational burden. Using ISO IDMP and the emerging IDMP Ontology as the backbone, the session will illustrate how semantic standards can reduce regional divergence, strengthen regulatory trust, and allow first movers to thrive in a landscape increasingly shaped by digital standards, AI‑enabled submissions, and global harmonisation efforts.

Show More

This session explores how digital transformation can elevate back office operations beyond pure efficiency, transforming them into empathy‑driven systems that strengthen trust and customer relationships. Maurice will share global insights on integrating technology with human expertise to build resilient, customer‑centric banking models for the future.

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Astellas logo.svg
template5

Yuri van Geertruij

Executive Director, Sub-Regional Lead for Mid-Sized Markets

CASE STUDY

Creating Value for Patients: Integrating Regulatory Affairs and Pharmacovigilance

In today’s pharmaceutical environment, consolidating RA and PV can deliver significant advantages – a common strategic focus on maximising portfolio success for the ultimate benefit of patients. This session is about sharing a journey of transforming two functions into a single organisation.

In this session, I’ll explore the critical role of being the bridge between product and technology, where true product development excellence happens. Drawing on my experience in transformation, including agile transformation and large-scale delivery, I’ll share how connecting vision with execution, and people with purpose leads to better collaboration, stronger outcomes, and more impactful products — the cornerstone of product and agile excellence.

Show More
Katherine-Tyner---Johnson-&-Johnson2Katherine-Tyner---Johnson-&-Johnson2
Johnson Johnson New 2023 Vertical Logo Vector.svg
Katherine Tyner Johnson Johnson

Katherine Tyner

Senior Director, Regulatory Policy Leader EMEA & CMC

CASE STUDY

When Innovation Meets Faster Than Regulations - Collaborating to Advance Transformational Medical Products

Innovation throughout the entire drug development lifecycle. Rapid advances in pharmaceutical science—spanning gene and cell therapies, digital health technologies, artificial intelligence–driven drug development, and novel clinical trial designs—are increasingly outpacing the pace of regulatory evolution. This innovation–regulation gap presents both challenges and opportunities for industry and regulatory authorities, particularly the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Proactive, structured partnerships offer a path to ensure that regulatory frameworks remain fit for purpose while enabling timely patient access to safe, effective, and high‑quality therapies.

Collaborative mechanisms such as parallel scientific advice, innovation offices, regulatory sandboxes, qualification programs, and real‑world evidence pilots allow regulators and developers to co‑create scientific understanding, reduce uncertainty, and accelerate development pathways. This abstract explores how coordinated engagement between pharmaceutical companies and regulatory bodies can support regulatory agility, promote global harmonisation, and foster responsible innovation in an era where scientific discovery is moving at unprecedented speed.

Show More

Three years ago, we set out to rebuild our organisation around the customer journey, rather than brands and channels. We introduced agile, cross-functional teams and created new roles, which are accountable for optimising key touchpoints across personas and channels. Through regular huddles with the Field Force, Medical, and Content Strategy teams, we turned insights from the field into rapid experiments and visible improvements. In this session, I will share how we designed these roles, how the huddles work in practice, and what we learned, both culturally and structurally, along the way.

Nina-Raic---Teva-Pharmaceuticals2Nina-Raic---Teva-Pharmaceuticals2
TevaPharm
Nina Raic Teva Pharmaceuticals

Nina Raic

Senior Director Regulatory Affairs

CASE STUDY

Navigating Complexity into Predictable Outcomes: Regulatory Excellence in Emerging Markets

Emerging markets present some of the most diverse and fast-evolving regulatory environments in the world, marked by varying requirements, language barriers and limited harmonisation. For global organisations, this complexity can create unpredictability, operational risks and barriers to timely submissions and approvals. Presentation explores a strategic risk-model approach to transforming regulatory complexity into predictable outcomes. Drawing from real-world operational challenges, it highlights how structured data models, aligned terminology, clear governance, and capability setting can reduce variability and strengthen decision-making. Participants will gain a framework that can help enhance regulatory consistency, improve data quality and build future-ready regulatory operations that remain resilient in the face of changing global regulatory environments.

Show More
Urszula-Ścieszko-Fic---Gedeon-richter2Urszula-Ścieszko-Fic---Gedeon-richter2
Gedeon Richter 199x
Urszula Scieszko Fic Gedeon richter

Urszula Ścieszko-Fic

Global Regulatory Intelligence & Regional Office Head

CASE STUDY

Beyond Compliance: How Regulatory Intelligence Drives Business Decisions

Regulatory Affairs is no longer a support function – it is a strategic driver of business performance. In an environment defined by acceleration, digitalisation, and zero tolerance for error, companies that fail to integrate regulatory intelligence into decision-making risk delays, inefficiencies and lost opportunities.

 This session explores how global regulatory trends are reshaping the role of Regulatory Affairs – from execution to strategy – and how organisations can translate intelligence into faster approvals, better portfolio choices and sustainable competitive advantage.

At Accor, our journey in embedding Strength-Based Leadership and building an ecosystem of coaches is a strategic priority and a cornerstone of our people development philosophy.

In our pursuit of a coaching culture, we’ve implemented a range of initiatives that bring together the best different developmental resources. These initiatives are not standalone programmes; they are part of a deliberate, connected effort to empower our leaders and teams. By focusing on individual and collective strengths, and grounded in core coaching principles, we are shaping a workplace where continuous learning, empathy, and performance go hand in hand. This culture fosters not only personal growth but also drives team resilience, engagement, and business impact.

Rather than just talking about the theory, we want you to hear directly from our leaders. They will share how adopting a coaching mindset has transformed their leadership and the tangible difference it has made for their teams and the organisation as a whole.

Show More
Sheila-Elz---Boehringer-Ingelheim2Sheila-Elz---Boehringer-Ingelheim2
Boehringer Ingelheim Logo.svg
Sheila Elz Boehringer Ingelheim

Sheila Elz

Senior Regulatory Information Manager

CASE STUDY

Data Quality by Design: How IDMP Ontology Accelerates Global Regulatory Harmonisation

As regulatory ecosystems shift toward data‑driven, modular, and globally aligned operating models, the quality and interoperability of regulatory data are becoming decisive strategic differentiators. This presentation explores how strong data foundations—governance, metadata discipline, and cross‑system interoperability—enable organisations to turn data into strategy rather than into an operational burden. Using ISO IDMP and the emerging IDMP Ontology as the backbone, the session will illustrate how semantic standards can reduce regional divergence, strengthen regulatory trust, and allow first movers to thrive in a landscape increasingly shaped by digital standards, AI‑enabled submissions, and global harmonisation efforts.

Show More

This session explores how digital transformation can elevate back office operations beyond pure efficiency, transforming them into empathy‑driven systems that strengthen trust and customer relationships. Maurice will share global insights on integrating technology with human expertise to build resilient, customer‑centric banking models for the future.